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Dynaloc for Treatment of Femoral Neck Fractures

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ClinicalTrials.gov Identifier: NCT02030431
Recruitment Status : Terminated (overweight of hard-ware removals in the Dynaloc group)
First Posted : January 8, 2014
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Lars C. Borris, Aarhus University Hospital

Brief Summary:
A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared with three cancellous screws, for osteosynthesis of femoral neck fractures

Condition or disease Intervention/treatment Phase
Femoral Neck Fracture Device: Dynaloc Device: Cancellous screws Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dynaloc vs. Multiple Cancellous Screws for Treatment of Femoral Neck Fractures
Study Start Date : March 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cancellous screws
Patients in this group are having osteosynthesis with three screws
Device: Cancellous screws
Active Comparator: Dynaloc
Patients in this group are having osteosynthesis with Dynaloc (three screws fixed in a small plate)
Device: Dynaloc



Primary Outcome Measures :
  1. Shortening of the femoral neck [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Reoperation [ Time Frame: 1 year ]


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Ages Eligible for Study:   50 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult men or women (see age specifications below) with subcapital femoral neck fractures (stable or unstable) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
  • Patients between 50 and 69 years of age with any Garden type femoral neck fracture
  • Patients older than 70 years of age with femoral neck fractures Garden type I and II
  • Patients older than 70 years of age with a femoral neck fracture Garden types III and IV and contraindication to hemiarthroplasty.
  • Operative treatment within 4 days (i.e., 72 hours) of presenting to the emergency room.
  • Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
  • Anticipated medical optimalization of the patient for operative fixation of the hip.
  • Provision of informed consent by patient or proxy.
  • Low energy fracture (defined as a fall from standing height).
  • No other major trauma.

Exclusion Criteria:

  • Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
  • Retained hardware around the affected hip.
  • Abnormal opposite hip making end-point evaluation impossible
  • Infection around the hip (i.e., soft tissue or bone).
  • Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy).
  • Moderate or severe cognitively impaired patients (i.e., Six Item Screener with three or more errors).
  • Patients with Parkinson's disease (or dementia or other neurological deficit) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
  • Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030431


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
Aarhus University Hospital

Responsible Party: Lars C. Borris, Consultant of Orthopaedic surgery, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02030431     History of Changes
Other Study ID Numbers: 1-10-72-362-13
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries